Identity
- Device Name
- Gauze swabs EUDAMED
- Model / Reference
- EO sterile EUDAMED30-538-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941558089953 EUDAMED
- Basic UDI-DI
- 69415580gauzeswabEOIsJ2 EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intranasal splint, non-biodegradable
Gauze swabs by Allmed Medical Products Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69415580gauzeswabEOIsJ2 | Class I | Active |
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Manufacturer
- Manufacturer
- Allmed Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000007970
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d5d9d93d-e4a2-4548-812c-f95289cbc8c5 61 fields · synced Jun 20, 2026